Cerebral PalsyhemiparesisNCT04651283
Effect of Using Adaptive Seating Equipment on Hand Function
A study testing Traditional seat group and Adaptive seating equipment group in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Objective: The purpose of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Traditional seat group and Adaptive seating equipment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with hemiparetic cerebral palsy.
- The age of the selected children ranged from 3 to 6 years old.
- Degree of spasticity ranged from 1 to 1+, according to Modified Ashworth' Scale (Bohannon and Smith, 1987)
- They were able to follow instructions and understand commands included in both assessment and training procedures.
- They were able to sit independent with trunk control.
Who cannot join
- Children exposed to orthopedic surgeries or potolinium toxins injection in the last 6 mounth before intervention.
- Children with fixed upper limb deformities
- Children with hearing or visual impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using Adaptive Seating Equipment on Grasping and Visual Motor Integration in Children With Hemiparetic Cerebral Palsy
Objective: The purpose of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis. Subjects: A total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls), aged 3-6 years participated in this study. They were randomly assigned into control and study groups of equal numbers each consisted of fifteen children (n=15). Methods: Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment (3 sessions per week), to assess 2 subtests (the grasping skills and visual motor integration skills) for all children of both groups. Control group who received a specially selected physical therapy program for hand function on a standard chair seating. Study group who received the same selected program for hand function on adaptive swiss ball seating.
Read the detailed description
The aim of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis.
In this study, a total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls) aged 3-6 years, they were selected from general hospitals and private centers in kafr El-Sheikh government, randomly assigned to either the control group (n=15), who received a specially selected physical therapy program for hand function on standard chair seating, or the study group (n=15), who received the same selected program for hand function but on adaptive Swiss ball seating. Both groups received 3 sessions per week for 3 successive months. Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment, to assess 2 subtests (grasping skills and visual motor integration skills).
- Conditions
- Cerebral Palsy
- Being tested
- Traditional seat group, Adaptive seating equipment group
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional seat groupOther
Also called Occupational therapy program for upper limb while the child sitting on chair
Each child in the control group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day):
- Building towers and shapes with different textures weights and bright colors.
- Inserting different shapes in the correct hole.
- Dropping pellets.
- Stringing beads.
- Copying square and triangle.
- Opening the bottle and close it.
- Folding and Crumpling paper.
- Cutting paper by scissors.
- Tracing line and connecting dots.
- Reaching above the level of shoulder.
- Reaching across the midline.
- Squeezing water out of a sponge.
- Buttoning and unbuttoning button.
- Playing clapping games.
- Turning pages in a book.
- Lacing string.
- Picking up a small piece of food and bringing it into the palm.
- Moving a penny from the palm to the fingers.
- Removing socks.
- Brush the teeth.
Adaptive seating equipment groupOther
Also called Occupational therapy program for upper limb while the child sitting on adaptive seating equipment ( swiss ball)
Each child in the study group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day):
- Building towers and shapes with different textures weights and bright colors.
- Inserting different shapes in the correct hole.
- Dropping pellets.
- Stringing beads.
- Copying square and triangle.
- Opening the bottle and close it.
- Folding and Crumpling paper.
- Cutting paper by scissors.
- Tracing line and connecting dots.
- Reaching above the level of shoulder.
- Reaching across the midline.
- Squeezing water out of a sponge.
- Buttoning and unbuttoning button.
- Playing clapping games.
- Turning pages in a book.
- Lacing string.
- Picking up a small piece of food and bringing it into the palm.
- Moving a penny from the palm to the fingers.
- Removing socks.
- Brush the teeth.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive seating equipment group | Experimental | Study group who received the same selected program for hand function on adaptive swiss ball seating Receives: Other: Adaptive seating equipment group |
| Traditional seat group | Active comparator | Control group who received a specially selected physical therapy program for hand function on a standard chair seating. Receives: Other: Traditional seat group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change is being assessed in grasping score
Assessment of grasping using Peabody Developmental Motor Scale 2 the higher score means a better outcome
Measured: Change from Baseline grasping score assessed at 3 months
change is being assessed in visual motor integration score
Assessment of visual motor integration using Peabody Developmental Motor Scale 2 the higher score means a better outcome
Measured: Change from Baseline visual motor integration score assessed at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Feb 2018
- Primary completion15 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study group and control group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Abbass, Cairo University
- Investigators
- Mai Abbass, Ph.D., Study director, Cairo UniversityAhmed Mahrous, Msc, Principal investigator, Cairo UniversityElham Salem, Ph.D., Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651283
- Sponsor's protocol ID
- P.T.REC\012\001765
- Acronym
- hemiparesis
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Adaptive Seating Equipment on Grasping and Visual Motor Integration in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04651283
- Acronym / sponsor ID
- hemiparesis / P.T.REC\012\001765
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: The purpose of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis. Subjects: A total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls), aged 3-6 years participated in this study. They were randomly assigned into control and study groups of equal numbers each consisted of fifteen children (n=15). Methods: Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment (3 sessions per week), to assess 2 subtests (the grasping skills and visual motor integration skills) for all children of both groups. Control group who received a specially selected physical therapy program for hand function on a standard chair seating. Study group who received the same selected program for hand function on adaptive swiss ball seating.
Detailed description
The aim of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis.
In this study, a total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls) aged 3-6 years, they were selected from general hospitals and private centers in kafr El-Sheikh government, randomly assigned to either the control group (n=15), who received a specially selected physical therapy program for hand function on standard chair seating, or the study group (n=15), who received the same selected program for hand function but on adaptive Swiss ball seating. Both groups received 3 sessions per week for 3 successive months. Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment, to assess 2 subtests (grasping skills and visual motor integration skills).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study group and control group
| Arm | Type | Receives |
|---|---|---|
| Adaptive seating equipment group | Experimental | Other: Adaptive seating equipment groupStudy group who received the same selected program for hand function on adaptive swiss ball seating |
| Traditional seat group | Active comparator | Other: Traditional seat groupControl group who received a specially selected physical therapy program for hand function on a standard chair seating. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with hemiparetic cerebral palsy.
- The age of the selected children ranged from 3 to 6 years old.
- Degree of spasticity ranged from 1 to 1+, according to Modified Ashworth' Scale (Bohannon and Smith, 1987)
- They were able to follow instructions and understand commands included in both assessment and training procedures.
- They were able to sit independent with trunk control.
Key exclusion criteria (3 listed)
- Children exposed to orthopedic surgeries or potolinium toxins injection in the last 6 mounth before intervention.
- Children with fixed upper limb deformities
- Children with hearing or visual impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional seat groupAlso: Occupational therapy program for upper limb while the child sitting on chairEach child in the control group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day): 1. Building towers and shapes with different textures weights and bright colors. 2. Inserting different shapes in the correct hole. 3. Dropping pellets. 4. Stringing beads. 5. Copying square and triangle. 6. Opening the bottle and close it. 7. Folding and Crumpling paper. 8. Cutting paper by scissors. 9. Tracing line and connecting dots. 10. Reaching above the level of shoulder. 11. Reaching across the midline. 12. Squeezing water out of a sponge. 13. Buttoning and unbuttoning button. 14. Playing clapping games. 15. Turning pages in a book. 16. Lacing string. 17. Picking up a small piece of food and bringing it into the palm. 18. Moving a penny from the palm to the fingers. 19. Removing socks. 20. Brush the teeth. | Other | Traditional seat group |
| Adaptive seating equipment groupAlso: Occupational therapy program for upper limb while the child sitting on adaptive seating equipment ( swiss ball)Each child in the study group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day): 1. Building towers and shapes with different textures weights and bright colors. 2. Inserting different shapes in the correct hole. 3. Dropping pellets. 4. Stringing beads. 5. Copying square and triangle. 6. Opening the bottle and close it. 7. Folding and Crumpling paper. 8. Cutting paper by scissors. 9. Tracing line and connecting dots. 10. Reaching above the level of shoulder. 11. Reaching across the midline. 12. Squeezing water out of a sponge. 13. Buttoning and unbuttoning button. 14. Playing clapping games. 15. Turning pages in a book. 16. Lacing string. 17. Picking up a small piece of food and bringing it into the palm. 18. Moving a penny from the palm to the fingers. 19. Removing socks. 20. Brush the teeth. | Other | Adaptive seating equipment group |
Primary outcome
change is being assessed in grasping score
Time frame: Change from Baseline grasping score assessed at 3 months
Assessment of grasping using Peabody Developmental Motor Scale 2 the higher score means a better outcome
change is being assessed in visual motor integration score
Time frame: Change from Baseline visual motor integration score assessed at 3 months
Assessment of visual motor integration using Peabody Developmental Motor Scale 2 the higher score means a better outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai Abbass, Ph.D. study director
Cairo University
Ahmed Mahrous, Msc principal investigator
Cairo University
Elham Salem, Ph.D. study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional seat group and Adaptive seating equipment group in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change is being assessed in grasping score (time frame: Change from Baseline grasping score assessed at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.